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An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. 6 versions Re-verified since Dec 9, 2022, no change to tracked fieldsv12-v17
  2. Primary completion date: Oct 2024 to Jun 2031
    • Study completion date: Dec 2024 to Jun 2031
    • Secondary endpoints: 12 to 13
    v11
  3. 5 versions Re-verified since Jan 16, 2020, no change to tracked fieldsv6-v10
  4. Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Enrollment target: estimated 110 to confirmed 119
    v5
  5. Study sites: 8 to 24v4
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 1 to 8
    • Eligibility criteria expanded, about 141 words
    • Secondary endpoints: 9 to 12
    v3
  2. Eligibility criteria expanded, about 19 words
    • Secondary endpoints revised (9)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia
Trial Details
NCT Number NCT03424018
Lead Sponsor BioMarin Pharmaceutical
Conditions
(from sponsor)		 Achondroplasia
Related terms Achondroplasia, Bone Diseases, Bone Diseases, Developmental, Dwarfism, Genetic Diseases, Inborn, Musculoskeletal Diseases, Osteochondrodysplasias
Enrollment 119 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov